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EC Pledges $7.8M for Trials of HLH Therapeutic Antibody

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The European Commission awarded a consortium of European researchers €6 million (about $7.8 million) through its FP7 program to support clinical trials of NovImmune’s anti-IFNγ monoclonal antibody NI-0501, as a treatment for the orphan disease hemophagocytic lymphohistiocytosis (HLH). The disease, which typically manifests in pediatric patients, is caused by severe impairment of cytotoxic T cell function that triggers overactivation of the immune system. The disease is mediated to a large part by dramatic increases in IFNγ, and has a 40% mortality rate even with the current best available care.

NovImmune’s fully human anti-IFNγ has been progressed through Phase I clinical trials, and in animal models of HLH reversed organ pathology and normalized key clinical parameters. The EC-funded consortium, termed Flight HLH, will be headed by NovImmune and include the Meyer University Children Hospital (Florence, Italy), the Pediatric Hospital Bambino Gesú (Rome, Italy), and Lonza Biologics.

NovImmune is leveraging its monoclonal, and bispecific antibody platforms to develop therapeutic antibodies for the treatment of inflammatory diseases and immune-related disorders. The firm’s pipeline is headed by the Phase II-stage candidates. NI-0801 is a CXCL10-targeting antibody in development primarily for the treatment of primary biliary cirrhosis. NI-0401 is a CD3ε-targeting antibody in development for blocking abnormal cytokine-induced inflammation by targeting the T-cell receptor complex. The mAb has completed a Phase IIa trial in Crohn’s disease, and a Phase I/II open-label study in renal allograft transplant patients.

In addition to NI-0501, the firm’s currently Phase I-stage pipeline includes an anti-CCL5/Rantes mAb (NI-0701), and an IL-17 mAb (NI-1401), which was licensed to Genentech in 2010.

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